10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
DIASCREEN REAGENT STRIPS
FDA 510(k)
FDA Class 1
·Hematology
Sofia Strep A+ FIA, Sofia 2 Analyzer
FDA 510(k)
FDA Class 1
·Microbiology
VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GOBED II
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·January 21, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 27, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·December 19, 2022
RESTYLANE, RESTYLANE
FDA Adverse Event
Injury
·Q-MED·Product code LMH·July 11, 2013
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·December 19, 2022
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024